The SleepWeaver Anew Full Face Soft Cloth PAP Mask is intended to provide an interface for Positive Airway Pressure (PAP) therapy. This mask is intended for single-patient reuse in the home and in the hospital/institutional environment. This mask is to be used on patients greater than 66 lbs (30 kg).

Device Description

The SleepWeaver Anew Full Face Soft Cloth PAP Mask consists of a cloth cushion, headgear, and a 90° elbow swivel connector with anti-asphyxia valve.

AI/ML Overview

The Circadiance LLC SleepWeaver Anew Full Face Soft Cloth PAP Mask is intended to provide an interface for Positive Airway Pressure (PAP) therapy. It is for single-patient reuse in home and hospital/institutional environments for patients greater than 66 lbs (30 kg).

1. Table of Acceptance Criteria and Reported Device Performance

Test/Evaluation Category	Acceptance Criteria (Implied)	Reported Device Performance
Material Evaluation	Materials suitable for intended use and patient contact	Biocompatibility requirements met, materials previously used or tested according to ISO 10993-1 and EDA G95-1.
Product Performance Testing	Device functions as intended for PAP therapy	Functioned as intended; results observed "as expected" for all tests (Physical Dead Space, Anti-Asphyxia Resistance, Anti-Asphyxia Operation, Pressure Drop, Carbon Dioxide Washout, Leak Rate).
Connector Performance	Connector functions as intended and safely	Functioned as intended; results observed "as expected".
Product Usability Evaluation	Device is usable by target population	Functioned as intended; results observed "as expected".
Biocompatibility	No adverse biological reactions	Biocompatibility requirements met. External surface of oral interface subject to Cytotoxicity, Sensitization, and Irritation testing.
Reliability	Device maintains performance over expected lifespan	Functioned as intended; results observed "as expected".
Packaging	Packaging protects the device and maintains sterility (if applicable)	Functioned as intended; results observed "as expected".
Accessory Interfacing	Device interfaces correctly with specified accessories	Functioned as intended; results observed "as expected".
Storage Testing	Device maintains integrity under specified storage conditions	Functioned as intended; results observed "as expected".
Labeling Review	Labeling is clear, accurate, and compliant	Functioned as intended; results observed "as expected".
Design Analysis	Design meets all functional and safety requirements	Functioned as intended; results observed "as expected".

2. Sample size used for the test set and the data provenance:

The document does not explicitly state the sample size used for each specific test or the data provenance (e.g., country of origin, retrospective/prospective). The performance data section lists various tests and evaluations, concluding with a general statement that "In all instances, the SleepWeaver Anew Full Face Soft Cloth PAP Mask functioned as intended and results of each test observed were as expected." This suggests the testing was likely internal validation rather than a clinical study with a large patient-based test set commonly associated with AI/software performance evaluations.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The device is a physical medical device (PAP mask), and its performance evaluation relates to physical and material properties, rather than diagnostic interpretation requiring expert-established ground truth like in AI algorithms.

4. Adjudication method for the test set:

Not applicable. The description of testing does not involve adjudication by multiple experts in the way an imaging diagnostic algorithm would. Performance was assessed through engineering and materials testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. The device is a PAP mask, not an AI-powered diagnostic tool, so an MRMC study comparing human readers with and without AI assistance is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not applicable. This device is not an algorithm. Its function is to provide an interface for PAP therapy, which inherently involves human interaction (patient wearing the mask).

7. The type of ground truth used:

For the performance testing mentioned (e.g., Physical Dead Space, Anti-Asphyxia Resistance, Pressure Drop, Carbon Dioxide Washout, Leak Rate), the "ground truth" would be established by industry standards, engineering specifications, regulatory limits, and established scientific principles for the safe and effective operation of PAP masks. For biocompatibility, the ground truth is established by international standards like ISO 10993-1.

8. The sample size for the training set:

Not applicable. This device is a physical medical device, not an AI algorithm, and therefore does not have a "training set" in the context of machine learning.

9. How the ground truth for the training set was established:

Not applicable, as there is no training set for this type of device.

Summary

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510(k) SUMMARY

MAY 2 4 2013

Circadiance LLC SleepWeaver Anew Full Face Soft Cloth PAP Mask

David Groll CEO David.Groll@Circadiance.com

Circadiance, LLC 1060 Corporate Lane Export, PA 15632 Phone: (724) 858-2837 Facsimile: (412) 202-4583

Contact Person: Ryan T. Kasun, (724-327-0230, x201), rkasun@raqasolutions.com

Date Prepared: February 18 2013

Name of Device and Name/Address of Sponsor

SleepWeaver Anew Full Face Soft Cloth PAP Mask

Common or Usual Name

Full Face PAP Mask

Classification Name

BZD - ventilator, non-continuous (respirator); 21 CFR 868.5905

Predicate Devices

SleepWeaver élan Nasal CPAP Mask Circadiance, LLC Common/Usual Name: Nasal CPAP Mask Classification: 21 CFR 868.5905 Product Code: BZD Panel: Anesthiesiology

Mirage Quattro ResMED, Ltd. Common/Usual Name: Full Face PAP Mask Classification: 21 CFR 868.5905 Product Code: BZD Panel: Anesthiesiology

Intended Use / Indications for Use

Circadiance, LLC

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Technological Characteristics

The SleepWeaver Anew Full Face Soft Cloth PAP Mask consists of a cloth cushion, headgear, and a 90° elbow swivel connector with anti-asphyxia valve.

The optional SleepWeaver FeatherWeight tube may be used with this mask, but it remains outside the scope of this submission as it has been previously cleared by its inclusion in K120757.

Performance Data

Performance testing for the SleepWeaver Anew Full Face Soft Cloth PAP Mask included the following tests or evaluations:

Material evaluation; .
Product performance testing: .
- Physical Dead Space: ্র
- Anti-Asphyxia Resistance: 0
- Anti-Asphyxia Operation: 0
- Pressure Drop: 0
- Carbon Dioxide Washout: and ం
- Leak Rate. 0
. Connector performance testing;
Product usability evaluation; t
Biocompatibility: .
- Patient Contract Duration: Permanent o
- Gas Pathway (External Communicating) Components 90° swivel with anti-্রে aspliyxia valve, mask body material, nasal interface, and internal surface of the oral interface. The materials in these components have been used in legally marketed devices. Biocompatibility requirements met.
- Surface Contact (Skin) Components: Headgear / mask wings . external с surface of the oral interface. The headgear material has been used in legally marketed devices: The material used for the external surface of the oral interface represents a material not previously used in a legally marketed device and was, subsequently, subjected to Cytotoxicity, Sensitization, and Irritation testing according to the guidelines set by ISO 10993-1 and the EDA G95-1 memorandum: Biocompatibility requirements met.
Reliability:
Packaging: .
Accessory interfacing: .
Storage testing: .
Labeling review; and .

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. Design analysis.

In all instances, the SleepWeaver Anew Full Face Soft Cloth PAP Mask functioned as intended and results of each test observed were as expected.

Circadiance, LLC

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 24, 2013

Mr. David Groll Chief Executive Officer Circadiance, LLC 1060 Corporate Lane Export, PA 15632

Re: K130481

Trade/Device Name: SleepWeaver Anew Full Face Soft Cloth PAP Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: Class II Product Code: BZD Dated: April 26. 2013 Received: May 6, 2013

Dear Mr. Groll: ·

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Groll

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Susan Ruan, DDS, AIA

Digitally signed by Mary S. Runner - 5
DN: c=US, o=U.S. Government, ou=HHS,
ou=FDA, ou=People, cn=Mary S. Runner -
5, 0.9.2342.19200300.100.1.1=1300087950
Date: 2013.05.23 14:59:36 -04'00

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Traditional 510(k) Tab 5 - Indications For Use Statement SleepWeaver Anew Full Face Soft Cloth PAP Mask

Indications for Use Statement

K130481 510(k) Number (if known):

Device Name: SleepWeaver Anew Full Face Soft Cloth PAP Mask

Indications for Use:

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Amv	· K. Levelle ··STATE
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2013.05:2	04'00'310:53the same of the states of the states4.4 4.9

(Division Sign-Off) Division of Anesthestology, General Hospital Infection Control, Dental Devices

K130481 510(k) Number:

Circadiance, LLC

February 22, 2013

Page 5-2

Regulation Number and Section

§ 868.5905 Noncontinuous ventilator (IPPB).

(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).